The Food and Drug Administration is the government agency charged with overseeing the nation’s pharmaceuticals for safety and effectiveness. It recently signed approval for a new mRNA flu shot made by the company Moderna, whose first product was the COVID shot. The news was perhaps inevitable but that doesn’t make the questions go away.
These shots designed for a different respiratory infection are routinely given to the elderly who worry about seasonal flu, people who might not know to ask what it is they are getting. With the FDA stamp of approval, they might not know it is something about which they should worry. Namely, the shot deploys highly questionable mRNA technology, the trials of which have layers upon layers of questionable assumptions and imprecisions.
The issues come down to pooled data from three separate trials. It appears that the company mushed together results from separate trials in a way that hid crucial signals concerning both efficacy and safety. It seems incredible until you realize that these companies specialize in constructing results designed to please regulators.
Per usual, the trials were not purely controlled experiments with one group receiving a placebo and the other receiving the proposed product. Instead—and this has become conventional in this industry—the new product is measured against the existing flu shot. If they can show a benefit over the status quo, however marginal, the new product is approved.
In this way, new products are increasingly grandfathered in based on approvals of old products. How it performs against a placebo which is what we really want to know, is the great unknown, even now. How they get away with doing this is another matter.
The headline number from the trials is that it has “26.6 percent relative efficacy.” In terms of common sense, this means nothing more than a 26 percent difference between the small number of people who did not get sick versus the same from the other group. Relative risk, one learns from reading this literature, is often a mathematical ruse.
In absolute terms, the vaccine reduced the risk of illness by just 0.8 percent.
It’s the habit of pharmaceutical trials to report relative efficacy and in percentage terms. This is weird. For example, a risk falling from 2 percent to 1 percent is reported as a “50 percent relative risk reduction.”
This kind of reporting became a serious issues with the COVID shots. Early mRNA vaccine trials reported efficacy of 95 percent, but this was actually relative risk reduction. In the actual trial data, infection rates were low, roughly 0.75 percent in the placebo group versus 0.04 percent in the vaccinated group for one major trial, yielding an average risk reduction of only 0.7 percentage points.
The relative number that dominated public communication and was interpreted by the public as 95 percent of vaccinated people are protected.” Or perhaps that the shot protects 95 percent of the time. Neither was ever true, not even close.
In contrast, the financial industry is more precise in language, always speaking of basis points rather than misleading reports of percents of percents. So when interest rates move from 5 percent to 5.1 percent, that is a 10 basis point increase whereas pharmaceutical reporting would describe that as a 2 percent increase.
Most concerning, however, were the serious adverse event (SAE) data. The six-month data show that 449 participants in the mRNA group experienced at least one SAE, compared with 389 in the conventional group. That’s an excess of 60 people. So, while the pivotal trial showed there were 4 fewer influenza hospitalizations in the mRNA group, 60 additional people experienced a serious adverse event.
SAEs are not mild events. As Demasi says, “they are usually severe enough to require hospitalisation, threaten life, cause significant disability, or result in death. The imbalance of SAEs in Moderna’s pivotal trial was statistically significant—meaning it was unlikely to be a random fluke.”
Once the pivotal trial P304 was combined with the other trials, the SAE rate became 3.1 percent in the mRNA group versus 2.9 percent in the comparator group. This sounds like nothing, thus allowing the FDA to state that the rates were “balanced.”
Pooling data across clinical trials is common when regulators are looking for rare events. But the four trials Moderna pooled were very different in many aspects. When these disparate trials were combined into a single analysis, the safety signal that stood out in the large pivotal trial was diluted.
Did Moderna trick the FDA? Apparently not. The FDA wrote that differences between the trials could produce safety variations “not fully captured by pooled analyses.” So they knew! That did not stop them. They approved this product anyway.
The deeper dive shows even more concerning data manipulations. They took the best safety data and the best efficacy data from each of the trials and merged them to obscure the bad news. Incredibly, writes Demasi, “Moderna’s own trial investigators assessed one of the five deaths in the mRNA group as caused by the vaccine—the same product that has now been licensed.”
In short, the new shot is more dangerous and probably less effective than that which it replaces, which in turns says nothing about the dangers and safety profile of the existing shot. Once you see how crazy this system is, you nearly cannot believe it, both that a manufacturer would do this and that the FDA would allow companies to get away with this stuff.
The entire system of pharmaceutical approvals relies on trust—trust of the trials, trust of the reporting, and trust in the FDA to serve as a cop on the beat to make sure that everyone is honest. A deep dive—which only highly competent statisticians and experienced journalists can do—can reveal shocking anomalies such as with this one.
What are consumers to do when that trust is broken? One hopes that in this case, the CDC will refrain from recommending this product and perhaps even that the parent agency, the Department of Health and Human Services, will intervene.
The Moderna shot has been a source of controversy for years. The former head of the FDA, Marty Makary, and his lead scientist, attempted to stop its approval. But meanwhile, Blackstone had already invested an astonishing $730 million in its development. Would we be naive to believe that this did not have something to do with the sudden reversal?
We have to ask what is more important, the health of the American people or the profits of the industry? In the end, we have to choose. Or more precisely: we have little to do with the decision and neither does evidence-based science. It’s the money that talks.
